NCT06562738

Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: The Third People's Hospital of Chengdu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated, single-arm, prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery

Detailed description

It was planned to include 55 patients with immune thrombocytopenia with preoperative platelet ≤75×10\^9/L. After signing the informed consent letter, the patients will enter the screening period (up to 7 days), and after passing the screening, they will receive oral hexapopal treatment, the specific medication regimen is: 7.5mg, once a day, taken orally on an empty stomach before going to bed, for a maximum of 14 days, and stop the drug when PLT≥100×10\^9/L. During the oral administration of hexapopal, the administration was suspended when PLT≥200×10\^9/L, and continued when the blood image was monitored weekly until PLT \< 100×10\^9/L. During the treatment period, blood routine was monitored every 7 days, and when PLT≤30×10\^9/L or ≥300×10\^9/L, blood routine was monitored every 3 days. Patients will have an end-of-treatment visit within 7 days of stopping treatment, followed by a 30-day safe follow-up period.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Hetrombopag	Hetrombopag 7.5 mg, once a day, at bedtime for up to 14 days, drug administration was stopped when PLT≥100 ×10\^9/L, and take blood routine examination weekly, drug administration was resumed when PLT \< 100 ×10\^9/L. When PLT ≤30× 10\^9/L or ≥300 ×10\^9/L, take blood routine examination every 3 days.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-01-31
• Completion: 2025-03-31
• First posted: 2024-08-20
• Last updated: 2024-08-20

Locations

1 site across 1 country: China